Effect of tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO® study

Yoshiaki Minakata, Takashi Motegi, Jun Ueki, Yasuhiro Gon, Shuhei Nakamura, Tatsuhiko Anzai, Kazuto Hirata, Masakazu Ichinose, Yoshiaki Minakata, Takashi Motegi, Jun Ueki, Yasuhiro Gon, Shuhei Nakamura, Tatsuhiko Anzai, Kazuto Hirata, Masakazu Ichinose

Abstract

Background: Patients with COPD are less physically active. This post hoc analysis of a randomized, double-blind, active-controlled, crossover trial assessed the efficacy of once-daily tiotropium/olodaterol combination therapy versus tiotropium monotherapy in Japanese patients with COPD.

Patients and methods: Patients were provided with a three-axis accelerometer to measure sedentary and active behavior defined as 1.0-1.5 metabolic equivalents (METs), ≥2.0 METs, and ≥3.0 METs, respectively. Of the 182 patients enrolled, 131 satisfied the conditions for the present analysis and were randomized to tiotropium monotherapy (n=62) or tiotropium/olodaterol combination therapy (n=69).

Results: Tiotropium/olodaterol combination therapy significantly reduced the duration of 1.0-1.5 MET activity by 8.64 mins (p=0.040) and significantly increased the duration of ≥2.0 MET and ≥3.0 MET activity by 6.51 mins (p=0.017) and 2.60 mins (p=0.008), respectively, compared with tiotropium alone. Subgroup analyses showed that better lung function, milder dyspnea, and higher levels of physical activity at baseline were associated with reduced sedentary time and increased duration of physical activity.

Conclusion: Tiotropium/olodaterol combination therapy significantly reduced sedentary time and improved physical activity compared with tiotropium monotherapy. This trial was registered in ClinicalTrials.gov (NCT02629965).

Keywords: COPD; Japanese; physical activity; sedentary behavior.

Conflict of interest statement

Y. Minakata reports non financial support from Nippon Boehringer Ingelheim, during the conduct of the study and personal fees from Nippon Boehringer Ingelheim, outside the submitted work. T. Motegi reports personal fees, non financial support from Nippon Boehringer Ingelheim, during the conduct of the study; personal fees from Nippon Boehringer Ingelheim, Fukuda Life Tech and AstraZeneca, outside the submitted work. J. Ueki reports personal fees from Nippon Boehringer Ingelheim, Hoshi Iryo Sanki, Teijin Pharma and Novartis Pharma, during the conduct of the study. Y. Gon reports personal fees from Nippon Boehringer Ingelheim, during the conduct of the study and personal fees from Novartis Pharma, Nippon Boehringer Ingelheim, Astra Zeneca and Kyorin Pharma, outside the submitted work. S. Nakamura is an employee of Nippon Boehringer Ingelheim. T. Anzai reports compensation for statistical analysis services from Nippon Boehringer Ingelheim during the conduct of the study and outside the submitted work. K. Hirata reports non financial support from Nippon Boehringer Ingelheim, during the conduct of the study and personal fees from Nippon Boehringer Ingelheim, outside the submitted work. M. Ichinose has received honoraria from AstraZeneca, Nippon Boehringer Ingelheim, and Novartis Pharma. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Patient disposition. Note:aReasons for valid days included days with ≥10 hrs’ wearing time and non-rainy days.
Figure 2
Figure 2
Activity durations for 1.0–1.5 METs (A), ≥2.0 METs (B), and ≥3.0 METs (C). Notes: Error bars represent SEs. Abbreviations: Adj., adjusted; METs, metabolic equivalents; Tio, tiotropium; T+O, tiotropium/olodaterol.
Figure 3
Figure 3
The effect of tiotropium/olodaterol combination therapy versus tiotropium monotherapy in time spent on 1.0–1.5 METs (A), ≥2.0 METs (B), and ≥3.0 METs (C) activity levels (change from baseline) by subgroups defined by baseline factors. Abbreviations: BMI, body mass index; IC, inspiratory capacity; METs, metabolic equivalents; SGRQ, St George’s Respiratory Questionnaire; Tio, tiotropium; T+O, tiotropium/olodaterol.
Figure 4
Figure 4
The relationship between improvements in lung function during treatment and duration of 1.0–1.5 MET (A), ≥2.0 MET (B), and ≥3.0 MET (C) activity levels (change from baseline). Abbreviations: IC, inspiratory capacity; METs, metabolic equivalents; SGRQ, St George’s Respiratory Questionnaire; Tio, tiotropium; T+O, tiotropium/olodaterol.

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Source: PubMed

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